Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
17 participants
INTERVENTIONAL
2017-05-31
2018-02-19
Brief Summary
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Detailed Description
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The main function of brown adipose tissue (BAT) is non-shivering thermogenesis (i.e. heat production through energy dissipation) in brown adipocytes. There has been a growing interest in BAT as a novel therapeutic approach to increase energy expenditure in order to facilitate weight-loss and increase insulin sensitivity.
BAT activity will be assessed using calorimetric test and \[18F\]-Fluorodeoxyglucose (FDG) positron emission tomography (PET).
We speculate that statins inhibit BAT function and that this mechanism may contribute to the above mentioned increase in insulin resistance.
Conditions
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Keywords
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Study Design
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SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
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Experimental
Volunteers receive calorimetric tests and FDG PET scans pre and post 2 weeks of Fluvastatine.
Fluvastatin
Fluvastatin 40 mg twice daily per mouth for 14 days.
Interventions
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Fluvastatin
Fluvastatin 40 mg twice daily per mouth for 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* body mass index 19 to 27 kg/m²
* Fluent in German or English
Exclusion Criteria
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
* Clinically indicated intake of the following medications: Corticosteroids, CYP3A4-Inhibitors (Itraconazol, Voriconazol, Fluconazol, Clarithromycin, Erythromycin, Indinavir, Nelfinavir, Ritonavir, Grapefruit juice), Beta-Blocker, Neuroleptics, Tricyclic Antidepressants,
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Participation in another study involving ionizing radiation in the same year,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* MRI contraindications: Not MRI-compatible metal in the body, cardiac pacemaker, History of surgery with possible metal clips/parts still in the body, claustrophobia.
* Resting pulse rate \> 70 bpm
* Known arterial hypertension or resting blood pressure \> 130/80 mmHg.
* frequence corrected QT-time (QTc) \>430 ms
* Serum creatinine \> 1.5x upper limit of norm (ULN), i.e.\> 145 µmol/L
* creatine kinase \> 1.5x ULN, i.e. \> 300 U/L
* aspartate transaminase (ASAT) \> 1.5x ULN, i.e. \> 51 U/L
* alanine aminotransferase (ALAT) \> 1.5x ULN, i.e. \> 88 U/L
* Hypothyroidism
* Vitamin D deficiency, Vitamin D3 \< 25 nmol/L
* Intake of anticoagulants or inhibitors of platelet aggregation (e.g. Aspirin, clopidogrel).
* Known tendency to form keloids (hypertrophic scar tissue)
18 Years
40 Years
MALE
Yes
Sponsors
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University of Basel
OTHER
University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Irene A Burger, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
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University Hospital of Zurich, PET/MR Center
Schlieren, Canton of Zurich, Switzerland
University Hospital of Basel
Basel, , Switzerland
Countries
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References
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Cypess AM, Weiner LS, Roberts-Toler C, Franquet Elia E, Kessler SH, Kahn PA, English J, Chatman K, Trauger SA, Doria A, Kolodny GM. Activation of human brown adipose tissue by a beta3-adrenergic receptor agonist. Cell Metab. 2015 Jan 6;21(1):33-8. doi: 10.1016/j.cmet.2014.12.009.
Preiss D, Seshasai SR, Welsh P, Murphy SA, Ho JE, Waters DD, DeMicco DA, Barter P, Cannon CP, Sabatine MS, Braunwald E, Kastelein JJ, de Lemos JA, Blazing MA, Pedersen TR, Tikkanen MJ, Sattar N, Ray KK. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis. JAMA. 2011 Jun 22;305(24):2556-64. doi: 10.1001/jama.2011.860.
Puurunen J, Piltonen T, Puukka K, Ruokonen A, Savolainen MJ, Bloigu R, Morin-Papunen L, Tapanainen JS. Statin therapy worsens insulin sensitivity in women with polycystic ovary syndrome (PCOS): a prospective, randomized, double-blind, placebo-controlled study. J Clin Endocrinol Metab. 2013 Dec;98(12):4798-807. doi: 10.1210/jc.2013-2674. Epub 2013 Oct 23.
Duvnjak L, Blaslov K. Statin treatment is associated with insulin sensitivity decrease in type 1 diabetes mellitus: A prospective, observational 56-month follow-up study. J Clin Lipidol. 2016 Jul-Aug;10(4):1004-1010. doi: 10.1016/j.jacl.2016.04.012. Epub 2016 May 10.
Chapple CR, Dvorak V, Radziszewski P, Van Kerrebroeck P, Wyndaele JJ, Bosman B, Boerrigter P, Drogendijk T, Ridder A, Van Der Putten-Slob I, Yamaguchi O; Dragon Investigator Group. A phase II dose-ranging study of mirabegron in patients with overactive bladder. Int Urogynecol J. 2013 Sep;24(9):1447-58. doi: 10.1007/s00192-013-2042-x. Epub 2013 Mar 8.
Loeliger RC, Maushart CI, Gashi G, Senn JR, Felder M, Becker AS, Muller J, Balaz M, Wolfrum C, Burger IA, Betz MJ. Relation of diet-induced thermogenesis to brown adipose tissue activity in healthy men. Am J Physiol Endocrinol Metab. 2021 Jan 1;320(1):E93-E101. doi: 10.1152/ajpendo.00237.2020. Epub 2020 Nov 23.
Fischer JGW, Maushart CI, Becker AS, Muller J, Madoerin P, Chirindel A, Wild D, Ter Voert EEGW, Bieri O, Burger I, Betz MJ. Comparison of [18F]FDG PET/CT with magnetic resonance imaging for the assessment of human brown adipose tissue activity. EJNMMI Res. 2020 Jul 22;10(1):85. doi: 10.1186/s13550-020-00665-7.
Other Identifiers
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FluvaBAT
Identifier Type: -
Identifier Source: org_study_id